PINNACLE 2218-28-062Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 62OD x 28ID NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295100263), received between Jul 24, 2020 and Jul 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
STAFF HAVE INDICATED THAT THE MENTIONED LINER TRIALS HAVE ALL BEEN STRIPPED AND NO LONGER PROPERLY WORK WITH THE SCREWDRIVER FOR INSERTION OR REMOVAL. THE LINER IMPACTOR HANDLE HAS BEEN CRACKED DUE TO WEAR AND TEAR AND ALSO NEEDS REPLACING. PLEASE SEND REPLACEMENTS AS SOON AS POSSIBLE. DID NOT OCCUR INTRA-OP AND THEREFORE NO PATIENT ISSUES OR SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS DIRECT TO THE FOLLOWING ADDRESS: (B)(6) . PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4).DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP (B)(4). DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP (B)(4). DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP (B)(4). DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP (B)(4). DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE M
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10323243 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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